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On May 21st Senator Patrick Leahy (D-VT) announced he was yanking the Patent Transparency and Improvements Act (S. 1720) he had introduced last November. This Bill represented the Senate’s attempt to work towards compromise legislation to trim the broader – and certainly more controversial – House Bill (H.R. 3309) that was passed last December. Just the day after Senator Leahy’s announcement, the House held a hearing at which legislation focused on regulating abusive patent infringement demand letters was discussed. This demand letter legislation was proposed by Rep. Lee Terry (R-NE) in a draft Bill entitled “Bill to Enhance Federal and State Enforcement of Fraudulent Patent Demand”. Representative Terry remarked that the Senate, by pulling its Bill now “puts us in a position where we have to do something”.

It has now been a week since the US Patent and Trademark Office held its public forum on the March 4th Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products (the Guidance). I was invited to present at this Forum, where I provided comments before the USPTO on the necessity for the Guidance, how the Guidance can be improved, and also provided cautions to prevent its misapplication. I had previously written about the Guidance in an earlier article on this site (see, How to Patent Grapefruit Juice: the New USPTO Guidance for Patent Eligible Subject Matter is Both Sticky and Sour).

Remember Dolly the sheep? She was the first mammal to be cloned from an adult somatic cell (a cell other than a sperm or egg cell) – that was in 1996. Well, Dolly is back again in the news, even though she passed away prematurely in 2003.

Last Thursday (May 8, 2014) the Court of Appeals for the Federal Circuit affirmed a ruling by the US Patent and Trademark Office’s Appeal Board that cloned animals are ineligible for patent protection under 35 USC § 101. The Court determined that “Dolly herself is an exact genetic replica of another sheep and does not possess markedly different characteristics from any [farm animals] found in nature.” The Court went on to say, “Dolly’s genetic identify to her donor parent renders her unpatentable.” See In re Roslin Institute (Edinburgh), 2013-1407.

Back in February I reported that the Supreme Court had a heavy patent docket during this 2013-14 term. See, Busy Schedule for the Supremes – Court Takes on Six High Profile Patent Cases This Term. On Tuesday of this week, the Court issued unanimous decisions in two of these cases: Octane Fitness, LLC v. Icon Health and Fitness, Inc., U.S., No. 12-1184, 4/29/2014 and Highmark Inc. v. Allcare Health Management Sys., U.S., No. 12-1163, 4/29/2014. In deciding these cases, the Court held that the Federal Circuit’s current standard for finding a patent case “exceptional” for the purpose of awarding attorneys’ fees to the prevailing party to be “unduly rigid.”

On March 4th the US Patent and Trademark Office issued guidelines to its examining corps for assessing patent eligible subject matter under 35 USC §101. The guidelines were issued in light of the Supreme Court’s decisions in Myriad, Prometheus, and related cases. See, “Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products.” The Guidance is intended to help examiners determine whether the subject matter of a patent claim is significantly different from what exists in nature.

The story continues to unfold regarding the patentability of diagnostics. At issue in Sequenom is US Patent No. 6,268,540. This patent is exclusively licensed to Sequenom and claims non-invasive prenatal diagnosis methods using maternal blood samples. The method provides an alternative to techniques such as amniocentesis, which can pose a risk to both the mother and child. Last year, in reviewing the ‘540 patent, the District Court for the Northern District of California issued an Order holding that medical diagnostic method claims are not eligible for patent protection.

The Supreme Court will hear six patent cases during the current 2013-14 term that began on October 7th of last year. This is an extraordinary number of patent cases, considering that the Court is scheduled to hear just 70 cases during this term, and that these 70 cases were selected from over 10,000 petitions for hearings (called writs of certiorari). In contrast, just three patent cases were heard during each of the 2010-11 and 2011-12 terms, and only two patent cases during the 2012-13 term.

The numbers are in for 2013. During the past year the US Food and Drug Administration approved 27 new drugs. This compares with a record 39 approvals for 2012 and 30 for 2011. But what does this mean? What’s in store for 2014?

Federal Circuit Decision will not Interfere with Interference
On November 5, 2013 the US Court of Appeals for the Federal Circuit handed down a decision in Sanofi-Aventis v. Pfizer Inc., 108 USPQ2d 1741. The decision is of interest because it had the potential to directly deal with the question of the patentability of biomolecules such as DNA and drug targets. However, the Court prudently exercised restraint in not doing so.

Are diagnostic claims now at risk?

On October 30, 2013 the United States District Court for the Northern District of California issued an Order holding that medical diagnostic method claims are not eligible for patent protection. See Ariosa Diagnostics, Inc. v. Sequenom, Inc., Case No. C 11-06391 SI. This District Court Order is significant because it was made upon remand and direction from the Federal Circuit to examine the subject matter eligibility of diagnostic patent claims in light of the Supreme Court’s recent decision in Association for Molecular Pathology v. Myriad Genetics, Inc.,133 S. Ct. 2107 (2013). However, the District Court decision is also potentially concerning because it raises the specter of whether lower courts will now feel compelled to issue rulings on important patent questions that are still evolving at the Supreme Court level. Some might even argue that these patent questions deal with important public policy issues that should more appropriately be addressed by the legislative branch and the US Patent and Trademark Office.